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The BEXCORE Vacuum Assisted Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities.

• It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
• It is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
  The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g. fibroadenoma, fibrocystic lesion), the BEXCORE Vacuum Assisted Breast Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

BEXCORE Vacuum-Assisted Breast Biopsy (hereinafter referred to as VABB) system is 'a set of equipment used for biopsy' composed of a sterilized disposable needle probe unit (hereafter Probe) and an electronic system unit. The electronic system unit consists of a driver and a main controller box (hereafter Main Body for main controller box). A biopsy needle-BXC135, BXC140, BXC145 are the Probes approved separately-is mounted on a driver, and then inserted into a breast. The inserted biopsy needle, powered by the motor in the Main Body of BXS100F, could be rotated or moved forward/backward to cut affected tissue of the breast. The cut tissues are pulled out by vacuum pressure to a filter mesh of Probe connected to the vacuum suction unit of BXS100F's Main Body. At the moment of completing tissue cut, the air supplied from a Main Body to the front part of the biopsy needle makes easy to discharge the cut tissue smoothly.

The provided text describes a 510(k) premarket notification for the BEXCORE Breast Biopsy System. It outlines the device's intended use, comparison to a predicate device, and performance testing. However, it does not contain explicit acceptance criteria or detailed results of a study proving the device meets those criteria.

The document discusses performance testing, but the results are summarized as "All of these performance tests demonstrate the device performs according to its intended use and meets the performance specifications," without providing specific numerical acceptance criteria or the reported performance values. It also doesn't detail clinical studies with human participants for effectiveness or safety beyond bench testing.

Therefore, I cannot fully complete the requested table and answer all questions based solely on the provided text. I will fill in what can be inferred or explicitly stated.

Here's an analysis based on the given information:

1. A table of acceptance criteria and the reported device performance

The document states, "All of these performance tests demonstrate the device performs according to its intended use and meets the performance specifications." However, it does not explicitly list numerical acceptance criteria or reported performance values for each test. The listed tests are primarily bench tests comparing the subject device to a predicate device, rather than specific quantitative readouts against pre-defined thresholds.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The text describes "non-clinical bench tests" and does not specify a sample size for these tests. It also does not mention the country of origin of the data or whether the tests were retrospective or prospective. These are typically simulated environments or direct measurements on the device itself, not human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document does not mention the use of experts to establish "ground truth" for the a test set in the context of diagnostic accuracy, as this is a device for tissue extraction, not a diagnostic AI algorithm. The performance tests are largely engineering/bench tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as this is for bench testing of a physical device, not a diagnostic study requiring human expert assessment and adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a biopsy system, not an AI-assisted diagnostic tool. No MRMC study was mentioned or implied.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (biopsy system), not an algorithm. Bench tests were performed on the device's physical and functional characteristics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance tests described, the "ground truth" would likely be engineering specifications, physical measurements, and comparison to the predicate device's known performance characteristics. For instance, for "Average Tissue Length" or "Average Tissue Weight," the ground truth would be the direct measurement of the extracted tissue. No mention of expert consensus, pathology, or outcomes data for performance testing of the device itself. The extracted tissue would then undergo histological examination, which is the standard of care, but that's a downstream process, not the "ground truth" for the device's performance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

Not applicable (as above).

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